MedTrace Logo

Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

NCT05295589 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-26

No results posted yet for this study

Summary

This phase II trial compares copanlisib and olaparib to standard of care chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that did not respond to previous platinum-based chemotherapy (platinum resistant) and that has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and olaparib may extend the time that the cancer does not progress compared to standard of care chemotherapy in patients with recurrent platinum resistant ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

  • Platinum-Refractory Fallopian Tube Carcinoma
  • Platinum-Refractory Ovarian Carcinoma
  • Platinum-Refractory Primary Peritoneal Carcinoma
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian High Grade Serous Adenocarcinoma
  • Recurrent Platinum-Resistant Fallopian Tube Carcinoma
  • Recurrent Platinum-Resistant Ovarian Carcinoma
  • Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
  • Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

Interventions

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Copanlisib Hydrochloride

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Olaparib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride

Given IV

DRUG

Topotecan Hydrochloride

Given IV

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Panagiotis A Konstantinopoulos · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-03-17
Completion
2023-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05295589 on ClinicalTrials.gov